November 6, 2014 — The FDA will add new warnings about side effects of heartburn drugs like Nexium, but they are stopping short of a “Black Box” warning about bone fractures and pneumonia.
The announcement came three years after the D.C.-based consumer advocacy group Public Citizen petitioned the FDA to update the labels. The group filed a lawsuit in April demanding a response.
In a response (PDF) dated October 31, the FDA agreed that heartburn medications in the proton pump inhibitor (PPI) class need new safety warnings. These drugs include Nexium, Dexilant, Prilosec, Segerid, Prevacid, Protonix, Aciphex, Vimovo, and generics.
Side effects added to the label include:
- Clostridium difficile-associated diarrhea
- Vitamin B12 deficiency
- Acute interstitial nephritis
- Recommended treatment length for gastroesophageal reflux disease (GERD)
- Drug interactions with methotrexate (a cancer drug that can remain in the body and become toxic) and mycophenolate mofetil
- Drug interactions with Plavix (clopidogrel), a blood-thinner that may be less effective in patients on heartburn drugs
However, they refused to add warnings about the pneumonia risk associated with bacterial overgrowth, saying the “risk and causal association are not well-established.” The FDA also refused to add a boxed warning about bone fractures.
Public Citizen applauded the decision and said the changes will make heartburn drugs safer, but they criticized the FDA for taking so long to respond:
“It is unconscionable that the agency took more than three years to respond. The evidence for all of the warnings now granted was available more than three years ago, but the agency unreasonably delayed, endangering millions of patients.”
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